BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX CA-1500

    MDR report key: 3601647 · Received January 16, 2014

    Report

    Report Number
    3009711478-2014-00002
    Event Type
    Other
    Date Received
    January 16, 2014
    Date of Event
    November 28, 2013
    Report Date
    December 23, 2013
    Manufacturer
    SYSMEX CORP
    Product Code
    GKP
    PMA / PMN Number
    K993299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVIDENCE OF PRODUCT MALFUNCTION WAS PROVIDED (ERROR LOG OR OTHER). IT IS NOT KNOWN IF THE ANALYZER WAS IN USE AT THE TIME. SIEMENS FIELD SERVICE EXAMINED THE ANALYZER AFTER THE EVENT. THE ENGINEER STATED THAT IT APPEARED TO HIM THAT THE WASTE LINE OF THE COAGULATION ANALYZER WAS MOVED DURING INSTALLATION OF TWO HEMATOLOGY ANALYZERS THAT SHARE THE DRAIN WITH THE COAGULATION ANALYZER AND THE LINE FROM COAGULATION ANALYZER WAS DISLODGED. NO PHOTOGRAPHS OR OTHER EVIDENCE TO SUPPORT OR CONFIRM THIS WAS SUBMITTED. THE FSE REPLACED THE WASTE LINE AT THE USER'S REQUEST. CURRENT STATUS OF THE USER IS NOT KNOWN. THIS OCCURRENCE IS REPORTED IN CONSIDERATION OF THE FDA NEEDLE-STICK GUIDANCE, AS (B)(6) WAS ADMINISTERED IN ADDITION TO FIRST AID.

    Description of Event or Problem · 1

    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS REPORTED TO SYSMEX CORPORATION (B)(4) AND SYSMEX AMERICA, INC. (SAI) ON (B)(6) 2013 AN INCIDENT OF POSSIBLE EXPOSURE TO A USER WHEN SHE MOVED A CART HOLDING A PRINTER AWAY FROM THE DRAIN AREA OF A CA-1500 AUTOMATED BLOOD COAGULATION ANALYZER (SERIAL NUMBER (B)(4)). THE USER WAS SPLASHED IN THE EYE WITH LIQUID WASTE. THE ISSUE OCCURRED ON (B)(6) 2013 AND WAS REPORTED TO SIEMENS ONE DAY LATER (B)(6). THE OPERATOR NOTICED MOISTURE ON A TONER BOX STORED ON THE CART. THE CART WAS LOCATED BETWEEN TWO RECENTLY INSTALLED SYSMEX HEMATOLOGY ANALYZERS; THE ANALYZERS SHARE THE DRAIN. WHEN THE CART WAS MOVED, ONE WASTE LINE, WHICH THE OPERATOR THOUGHT WAS THAT OF THE COAGULATION ANALYZER, CAME OUT OF THE DRAIN AND LIQUID SPLASHED IN HER EYES. THREE WASTE LINES CONVENE IN THIS DRAIN. THE USER IS CONCERNED THAT TOO MUCH PRESSURE IS FORCING DRAIN LINES TO COME OUT. ONE DRAIN LINE APPEARS TO COLLECT EXCESS FLUID. THE TECHNOLOGIST IMMEDIATELY FLUSHED HER EYES WITH WATER FOR 15 MINUTES AND WAS ASSESSED BY THE PATIENT CARE SUPERVISOR. SHE WAS TREATED IN OCCUPATIONAL HEALTH AT THE FACILITY FOR EXPOSURE. (B)(6) WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41930 SYSMEX CA-1500 AUTOMATED COAGULATION ANALYZER GKP SYSMEX CORP CA-1500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other